study of cyr-101 in patients with schizophrenia

Conditions: Schizophrenia

Summary: this phase ii study will test whether cyr-101, a cns-active compound with novel pharmacological profile and devoid of dopamine d2 receptor binding properties, is efficacious when administered orally in the management of patients with a diagnosis of dsm-iv schizophrenia.


Eligibility criteria:
inclusion criteria: * male or female patients, 18 to 65 years of age, inclusive * female patients must test negative for pregnancy and, if of childbearing potential, must be using a medically accepted means of contraception. * patients must have a diagnosis of schizophrenia or schizo-affective disorders as defined in diagnostic and statistical manual of mental disorders, fourth edition text revised (dsm-iv tr, apa 2000) (disorganised, 295.10; catatonic, 295.20; paranoid, 295.30; residual, 295.60; or undifferentiated, 295.90) and confirmed by the structured clinical interview for dsm-iv (scid). * patients must meet the following psychopathologic severity criteria at screening: positive and negative syndrome scale (panss) total score, of at least 60. * patients must receive a rating of 4 (moderately ill) or greater on the clinical global impression-severity (cgi-s) scale at screening. * patients in whom, in the opinion of the investigator, a switch to another antipsychotic medication or initiation of an antipsychotic medication is indicated. * patients must be considered reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol. * patients must be able to understand the nature of the study and have given their own informed consent. exclusion criteria: * are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. * have received treatment with a drug that has not received regulatory approval for any indication within 30 days prior to screening. * patients in whom treatment with cyr-101, or placebo, as specified in this protocol, is relatively or absolutely clinically contraindicated. * patients who have a history of an inadequate response, in the opinion of the investigator, to 2 or more adequate antipsychotic medication trials of at least 8 weeks duration in the past 12 months prior to screening. * patients who require concomitant treatment with any other medication with primary central nervous system activity, other than certain allowed medications as specified in study protocol. * patients receiving treatment with depot antipsychotic medication within 1 dosing interval, minimum of 4 weeks, prior to screening. * actively suicidal (for example any suicide attempts within the past month or any current suicidal intent including plan) in the opinion of the investigator or a score of 4 or greater on item 10 of the montgomery-asberg depression rating scale (madrs). * dsm-iv diagnosis of substance dependence or substance abuse (except nicotine and caffeine) within the 6 months prior to screening. * diagnosis of substance-induced psychosis by dsm-iv criteria within 7 days of screening (or at any time during the study). * patients with current heteroaggressive behavior. * female patients who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study. * have increased risk of seizures as evidenced by a history of: one or more seizures (except childhood febrile seizure), history of electroencephalogram (eeg) with epileptiform activity, history of stroke; surgery to the cerebral cortex; or head trauma with loss of consciousness. note: patients with a history of childhood febrile seizure may be enrolled in this study. * patients who have had electroconvulsive therapy (ect) within 3 months of screening visit or who will have ect at any time during the study. * test hiv positive. * test positive for hepatitis c antibody or hepatitis b surface antigen (hbsag). patients with positive hepatitis b core antibody test and negative hbsag may be included in the study if aminotransferase levels (alt/sgpt and ast/sgot) do not exceed 1.5 times upper limit of normal (uln). * alanine transaminase/serum glutamic-pyruvic transaminase (alt/sgpt) values \>1.5 times uln of the performing laboratory, or total bilirubin values \>2 times the uln or concomitant alt/sgpt values \>1.5 times the uln and total bilirubin values \>1.5 times the uln at screening. * patients with acute, serious, or unstable medical conditions, including (but not limited to) inadequately controlled diabetes (hemoglobin a1c (hba1c) \>8%), severe hypertriglyceridemia (fasting triglycerides \>5.6 mmol/l, recent cerebrovascular accidents, serious acute systemic infection or immunologic disease, unstable cardiovascular disorders (including ischemic heart disease), malnutrition, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, or haematologic diseases. * prolactin level at screening visit of greater than 200 ng/ml (or 200mg/l). * a diagnosis of parkinson's disease, dementia-related psychosis, or related disorders. if a patient has a past misdiagnosis of parkinson's disease, dementia-related psychosis, or related disorders, the investigator will need to contact the clinical research physician prior to enrolment. * patient with current clinically significant cardiovascular disease. * history of syncopal events due to cardiovascular abnormality.